Facilitating Diffusion of Subcutaneous Injection
Conditions
Interventions
control group:Single subcutaneous administration of normal saline
Sponsors
Beijing Tongren Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in the experiment and sign informed consent; 2. Male and female subjects aged 18-60 years (including 18 and 60 years); 3. Male subjects weighed no less than 50 kg and female subjects weighed no less than 45 kg. Body mass index (BMI) = body weight (kg) / height 2 (m2), and body mass index (BMI) ranges from 18 to 26 kg / m2 (including critical value); 4. No abnormalities considered clinically significant by researcher or a history of diseases such as heart, liver, kidney, digestive tract, nervous system, respiratory system, mental disorders and metabolic abnormality; no abnormality or abnormalities with clinical significance was found in physical examination, electrocardiogram and laboratory examination.
Exclusion criteria
Exclusion criteria: 1. HIV antigen/antibody, HCV antibody and syphilis specific antibody test results were positive or five abnormal hepatitis B cases. 2. Those who have a history of allergy to experimental drugs; 3. Severe smokers; 4. Alcoholics or those with positive breath test results; 5. Persons with a history of drug dependence and drug abuse; 6. Drug abuse urine screening positive; 7. Participants in other clinical trials within three months before screening; 8. Subjects or their partners who have family planning or are unwilling to take effective contraceptive measures during or within six months after the trial; 9. Researchers consider it inappropriate to participate in this study, or subjects are unable to participate in the experiment for their own reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AE;pharmacokinetics;positive rate of anti-drug antibodies; | — |
Countries
China
Contacts
Public ContactZheng Wang
Outcome results
None listed